The news: Novo Nordisk missed an important patent filing deadline in Canada for its weight loss and diabetes drug semaglutide, opening the door to generics as soon as next year.
How we got here: Novo Nordisk’s exclusivity for its GLP-1 semaglutide, branded as Ozempic, in Canada will expire in January 2026 because it didn’t pay maintenance fees on its patent filing, per a Science report. Under Canadian regulations, once a patent lapses, it can’t be revived.
Generic drugmaker Sandoz is now awaiting Health Canada approval to start selling semaglutide there, CEO Richard Saynor told Endpoints News. He noted that Canada is the second-largest market for the drug. For context: Novo’s US patent exclusivity for semaglutide is expected to hold until at least 2032.
Why it matters: Some Americans already cross the Canadian border—physically and via online Rx—for cheaper prescription drugs, but the Trump administration wants to formalize cross-border deals.
- President Trump’s prescription drug executive order in April re-ups a provision from his first administration to encourage the FDA to allow states to import lower-cost drugs from Canada.
- In early 2024, Florida became the first state, and still the only one, to receive FDA authorization to purchase and import some drugs for Medicaid recipients, state clinics and prisons. Florida expected to save $180 million in the first year, but a November report by KFF found Florida was still waiting for FDA feedback to launch the program.
- Other states, including Colorado, Maine, New Hampshire and New Mexico, have submitted proposals to the FDA for approval, per the National Conference of State Legislators.
However, drug importation would be difficult at scale and face regulatory and trade issues, per Bloomberg Law. Canada is also against US state imports over concerns of causing drug shortages there.
Our take: If Sandoz and other generic makers start selling semaglutide GLP-1 drugs in Canada next year, FDA approval for states may not matter. If drugmakers do start selling generic GLP-1s in Canada, Novo will see Ozempic brand sales drop, but the GLP-1 market could see a generics’ explosion.
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